This is the first of a tri-­‐annual newsletter from North Carolina
^ƚĂƚĞ hŶŝǀĞƌƐŝƚǇ͛Ɛ (NCSU) Masters in Biomanufacturing (BIOM)
program. This letter is sent to BTEC friends and colleagues in
the field of biomanufacturing and biopharmaceuticals to keep
them informed of updates, changes, and the latest happenings
at this exceptional new program.
The BIOM program is a rigorous, 44-­‐hour Professional Science
DĂƐƚĞƌ͛Ɛ(PSM) program focused on cross-­‐training individuals in
advanced scientific biomanufacturing theory as well as business
knowledge in bioscience management. The BIOM program is
based out of the 82,500 gross-­‐square-­‐foot, $50 million
Biomanufacturing Training and Education Center (BTEC) located
ŽŶ E^h͛Ɛ ĞŶƚĞŶŶŝĂů ĂŵƉƵƐ͘ BTEC, completed in 2007, is a
simulated cGMP facility offering industry-­‐scale, state-­‐of-­‐the-­‐art
equipment to train students and is the only training and
education facility of its kind.
The BIOM program was made possible due to a 3-­‐year,
$700,000 grant from the National Science Foundation. NCSU
ǁĂƐŽŶĞŽĨϮϭƵŶŝǀĞƌƐŝƚŝĞƐĂǁĂƌĚĞĚĂ^ĐŝĞŶĐĞDĂƐƚĞƌ͛ƐWƌŽŐƌĂŵ
grant out of more than 200 applicants from around the nation.

The Masters in Biomanufacturing Program

The BIOM PSM program is a new kind of degree that develops
ƚŽŵŽƌƌŽǁ͛Ɛ ůĞĂĚĞƌƐ ďǇ ĐƌŽƐƐ-­‐training individuals in not only their
specific scientific discipline, but also in related areas of management.
BIOM students will take a number of specialized courses including
Global Regulatory Affairs, Biopharmaceutical Protein Characterization,
Microbial Biotechnology, two semesters of Industry Practicum,
professional skills training, a required industry internship, as well as
their choice of focusing on either upstream or downstream processes.
Either of these concentrations will require small, intermediate, and
industry scale coursework.
Students are required to take a minimum of 6 hours of MBA
coursework if they are on a thesis-­‐based MS track, or 9 hours of MBA
coursework if they are completing the non-­‐thesis MR track.
In both cases all MBA classes are taken
Ăƚ E^h͛Ɛ ŚŝŐŚůǇ ƌĞƐƉĞĐƚĞĚ :ĞŶŬŝŶƐ
Graduate School of Management in
the Poole College of Management. The
BIOM program requires Project
Management and a Strategic
Management Foundations course.
Applicants come from a wide variety of disciplines including Chemical
Engineering, Biological and Bioprocess Engineering, Life Sciences,
Pharmaceutical Sciences, directly from industry, and other
undergraduate and graduate programs.

CompleƚĞĚŝŶϮϬϬϳŽŶE^h͛ƐĞŶƚĞŶŶŝĂůĂŵƉƵƐ͕dŝƐĂŶϴϮ͕ϱϬϬŐross-­‐square-­‐foot
facility dedicated to biomanufacturing training and education. It is a simulated cGMP facility
and the only one of its kind.

First Class now in Industry Internships
The first class of BIOM students have officially completed their
first year! Five of the six students have decided on the
downstream processing track and all six students are currently
working in their industry internships. Hope Metzler, Juan
Ceuva, and Veronica Adams are at Biogen Idec in Research
Triangle Park working in downstream processing. Sanaa
Elouafiq is at Arbovax, a small start-­‐up company, working on a
vaccine for Dengue Fever. Renee Berry is working in
granulation at Novozymes and Jane Winkleman continues to
work at Eisai.
The majority of the class and laboratory work for each of
the
students processing tracks were completed in their first year.
MBA courses and biomanufacturing research will be the
primary focus during the second year of the program. Multiple
students have expressed interest in obtaining their Biosciences
Management MBA at the Jenkins School of Management
following their BIOM graduation and those students will
therefore also be enrolled in prerequisite courses.
dŚŝƐ &Ăůů͛Ɛ ϱϵϬ͗ /ŶĚƵƐƚƌǇ WƌĂcticum in Biomanufacturing
course will focus on the production of Influenza Vaccine. The
case study will require students to visit industry facilities and
fully understand regulatory aspects in order to convert BTEC
into a fully functioning vaccine facility.

Since the inception of the NCSU
Biomanufacturing undergraduate minor 3 years
ago, BTEC students have 100% placement into
industry or advanced education.
NCSU was voted in Kiplinger Magazine as one of
the top 15 best values in public education.
Last year, BIOM students presented final
projects from BEC 590: Industry Practicum at the
North Carolina Biotechnology Center. Located in
Research Triangle Park, it the oldest
biotechnology center in the U.S.
Less than 4 years after opening its doors BTEC
exceeded its goal of 250 students per semester
target enrollment ʹ an annual growth rate of 41
percent!

The BIOM program was originally expected to be approved by the
University of North Carolina General Administration (UNCGA) by early
Spring 2011. However, due to the retirement of President Erskine Bowles
in early 2011 and the time spent searching for his subsequent
replacement in Thomas W. Ross, the anticipated approval of the program
has been pushed back. It currently stands that BIOM is the first program
to be reviewed in the new fiscal year starting July 1, 2011. It is expected
that BIOM will be fully accepted by Fall 2011.
Until BIOM is officially approved, it is being conducted as a subset of the
highly respected Chemical and Biomolecular Engineering department.
Potential students interested in applying for the program should apply to
the NCSU Graduate School under the Chemical EngineeringʹMR program.

>ŽŽŬŝŶŐƚŽƚŚĞ&ƵƚƵƌĞ͙
The BIOM program will grow to a minimum of 12
students per year within the next few years. BTEC
faculty understand that many of our future
students will come from an industry setting and
will likely be enrolled as part time students.

In order to better accommodate working
professionals, BTEC is already in the process of
moving as many classes as possible to outside-­‐of-­‐
work hours. This coming Fall, two courses will be
offered in the evening and one class will be
offered online.

Students learning the Column Chromatography techniques in BTEC Purification Suite

Graduate Minor Approved
Although the BIOM program is still awaiting final approval from the
UNCGA, the Graduate Minor in Biomanufacturing has been officially
approved. ͞This is a tremendous step forward for the graduate program
as a whole and now allows students from other programs to gain
valuable knowledge and hands-­‐on experience at BTEC͟ƐĂǇƐŚƌŝƐ^ŵŝƚŚ͕
Program Coordinator for the BIOM program.
For both Masters and Ph.D. Candidates, the graduate minor will require
2 credit hours of biomanufacturing research. The remaining credit hours
are elective classes to be chosen by the student. Although not a
requirement, we recommend students complete a FDA Regulatory
Compliance course and an upstream or a downstream track. Like the
BIOM program, a complete track includes small, intermediate, industry-­‐
scale process development and cGMP operations courses.

Keeping up with Industry

BTEC is dedicated to keeping up with the latest
trends in biomanufacturing. In order to make sure
students are receiving the most up-­‐to-­‐date
knowledge possible, BTEC keeps close ties with
industry personnel by holding frequent meetings
with the BTEC Advisory Board. The companies
represented in the Advisory Board include:

Graduate students planning to obtain the Graduate Minor in
Biomanufacturing would include individuals from Chemical Engineering,
Microbial Biotechnology, Microbiology, Food Science and Physiology.
The minimum credit hours for Masters students is 10, while the
minimum required credit hours for Ph.D. students is 12.